Biotech Values

[AlpineBV_Miller]

lol... Not sure exactly how to respond to this since the situation you describe essentially is a restarting of the trial.

FDA rules on SPAs specifically state you can't get one after the first patient is enrolled.

When launching a new trial under a SPA, you can piggyback on all your IRB approvals and your SAP/protocol filings. You can even use the same name/number for the trial for PR reasons. You can even use the patients already dosed as part of the safety database in your NDA/BLA filing. But, you have to start a new trial to get the SPA.

We went through this with INGN and their nonsense that they HAD a SPA on their Advexin Phase III trials, when the SPA program arrived well after the trials started. After asking the questions on their CC, they then shifted to "well, we have the same thing as an SPA." Incidentally, those questions got me booted from their CCs. Too bad as they are endlessly entertaining examples of management spin and obfuscation at their worst -- quarterly classrooms for biotech investors on what NOT to put your money into.